FDA Recalls Dental Resin Cartridges Due to Expiration Date Formatting Error
STRATASYS recalled TrueDent Clear dental resin cartridges due to an expiration date formatting error that prevents the system from recognizing expired material. Affected units could allow use of expired resin in dental appliance fabrication.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is a labeling and system error in expiration date formatting that could allow use of expired material, which is preventable and represents a theoretical risk rather than demonstrated harm.
Plain-English summary
STRATASYS LTD is recalling TrueDent Clear (TDM 100, Model No. OBJ-09164), a light-curable methacrylate-based resin used for fabricating dental appliances. The recall affects 78 units distributed nationwide.
A formatting error in the cartridge expiration date switches the day and month, causing the system to fail to recognize expired material. This could allow users to unknowingly employ expired resin in dental appliance fabrication.
The affected lots are Lot 22994 (expiration date 02-Apr-2024) and Lot 23425 (expiration date 07-Nov-2024). Users of these cartridges should contact STRATASYS LTD for replacement or additional guidance on affected units.
The recalled product
- Product
- TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Manufacturer
- STRATASYS LTD
- Hazard
- mis-labeling
- expired-material
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 7290018915004 Lots 22994 (exp. 02-Apr-2024) and 23425 (exp. 07-Nov-2024)
Distribution
Distributed nationwide across the United States.
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